510(k) DEN240021

Device

Tango® Belt (Model SAS-001-01 (XS); Model SAS-001-02 (S); Model SAS-001-03 (M); Model SAS-001-04 (L); Model SAS-001-05 (XL))

Applicant

Active Protective Technologies, Inc.

510(k) number

DEN240021

Product code

SEC

Decision

Unknown (DENG)

Decision date

2025-04-09

Date received

2024-05-16

Regulation

890.3780

Classification name

Wearable Fall Injury Prevention Device

Medical specialty

Physical Medicine

Review panel

Physical Medicine

Device class

2

Clearance type

Direct

Third party reviewed

N